Senior Analytical Scientist
Harleysville, PA - USA
Job Summary
Your New Company!
At Altasciences we all move in unison to assist and work in the discovery development and manufacturing of new drug therapies to get them faster to people who need them. No matter your role we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development Customer Focus Quality and Excellence Respect and Integrity we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people like you to join our growing team! Whether youre a recent college graduate or seeking your next career opportunity its time to discover your future at Altasciences.
We are better together and together We Are Altasciences.
About the role
A Senior Analytical Scientist in the Pharmaceutical and Analytical development function is a senior-level technical role focused on developing validating and applying analytical methods to support drug discovery development and quality assurance. The role blends deep technical expertise with leadership regulatory compliance and cross-functional collaboration.
What Youll Do Here
Design and manage analytical approaches to support early drug development projects (R&D Preclinical and Phase I Clinical) with a focus on chromatographic dissolution particle size distribution and spectrophotometry-based methods.
Oversee and review the planning development execution and interpretation of analytical studies performed by other scientists in a collaborative work environment.
Lead the development qualification validation and transfer of robust analytical methods ensuring high-quality data generation and reproducibility.
Collaborate cross-functionally to identify and apply optimal analytical techniques including computational modeling predictive tools and data visualization platforms.
Ensures analytical methods follow ICH Q2/Q14 principles.
Lead the planning execution and interpretation of analytical method studies ensuring high-quality reproducible data.
Evaluate scientific data to draw clear conclusions guide future work and communicate findings through presentations technical reports and other media.
Contribute to regulatory submissions by authoring relevant sections of the quality modules ensuring alignment with global standards.
Work with Formulation Development manufacturing and quality teams to select and apply optimal analytical techniques.
Lead analytical method development projects end to end and mentor junior scientists.
Develop and implement new analytical technologies and high-throughput workflows.
What Youll Need to Succeed
Bachelors in Engineering Chemistry Pharmaceutical Sciences or related field. Masters or PhD preferred.
8 years of current industry experience in analytical method development and qualification (8 years with Bachelors 5 years with Masters or 3 years with PhD).
Experience in modern dissolution method development and IVIVC.
Have a demonstrated history of applying current ICH/USP/BP/EP/JP guidance towards regulatory submissions.
Proficiency with computer office tools (Word Excel Outlook and miscellaneous scientific software)
Extensive hands-on experience with Quantitative tests such as Assay Content Uniformity Dissolution Particle Size Distribution Preservative Assay Related Substances Residual Solvents Resuspend ability Viscosity and other techniques for testing Drug Product Oral Solid dosage forms and data review in a pharmaceutical development and quality control laboratory setting.
Familiarity with a broad range of analytical techniques including HPLC/UPLC disintegrations compendial testing generic testing (e.g. UV KF titrations).
Proficiency in analytical instrumentation and troubleshooting.
Experience in a regulated laboratory environment (GLP/GMP).
Proven ability to mentor team members.
Independent thinker proactive mindset solution oriented can-do-attitude and results oriented to achieve successes while ensuring people-based leadership behavior.
Experience with multiple dosage forms (e.g. solid oral peptides sterile biologics or specialized manufacturing).
Detail-oriented with a high level of diligence.
Strong presentation and communication abilities.
Demonstrated interpersonal and facilitation skills.
Ability to thrive in a collaborative team-based environment.
Capable of managing multiple projects in a fast-paced setting.
Strong knowledge of laboratory CGMP regulations (FDA/EMA) and pharmaceutical quality systems.
Must be self-directed motivated and have a willingness to take the initiative to identify and anticipate client needs and make recommendations for implementation.
What We Offer
Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.
Altasciences Benefits Package Includes:
Health/Dental/Vision Insurance Plans
401(k)/RRSP with Employer Match
Paid Vacation and Holidays
Paid Sick and Bereavement Leave
Employee Assistance & Telehealth Programs
Telework when applicable
Altasciences Incentive Programs Include:
Training & Development Programs
Employee Referral Bonus Program
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MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH
Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract develop and retain highly talented employees from diverse backgrounds allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age race color religion creed sex sexual orientation gender identity national origin disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!
Required Experience:
Senior IC
About Company
Contract research organization specialized in seamless, end-to-end, early phase drug development, we act to get your most promising compounds into and through early phase clinical trials.